Knotless graft fixation assembly

ABSTRACT

An illustrative example suture securing assembly includes an inserter having a distal end, a proximal end, and a longitudinal axis between the distal end and the proximal end. A first member includes an eyelet oriented to thread suture across the longitudinal axis. The first member is situated near the distal end of the inserter. The first member is configured to be placed in bone. A second member is situated near the distal end of the inserter. The second member is moveable relative to the first member in a distal direction toward the eyelet into a suture securing position where the second member traps suture.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 13/765,218filed Feb. 12, 2013, which is a divisional of U.S. application Ser. No.13/182,893, filed Jul. 14, 2011, now U.S. Pat. No. 8,430,909, which is acontinuation of U.S. application Ser. No. 12/022,868, filed Jan. 30,2008, now U.S. Pat. No. 7,993,369, which is a continuation-in-part ofU.S. application Ser. No. 10/405,707, filed Apr. 3, 2003, now U.S. Pat.No. 7,329,272, which is a continuation-in-part of U.S. application Ser.No. 09/886,280, filed Jun. 22, 2001, now U.S. Pat. No. 6,544,281, whichclaims the benefit of U.S. Provisional Application No. 60/213,263, filedJun. 22, 2000.

BACKGROUND

When soft tissue such as a ligament or a tendon becomes detached from abone, surgery is usually required to reattach or reconstruct the tissue.Often, a tissue graft is attached to the bone to facilitate regrowth andpermanent attachment. Various fixation devices, including sutures,screws, staples, wedges, and plugs have been used in the past to securesoft tissue to bone. In typical interference screw fixation, forexample, the graft is fixed to the bone by driving the screw into ablind hole or a tunnel in the bone while trapping the end of the graftbetween the screw and the bone tunnel. In other methods, the graft issimply pinned against the bone using staples or sutures tied around theend of the graft to the bone.

More recently, various types of threaded suture anchors have beendeveloped. The application of such suture anchors generally requires thesurgeon to tie knots in the suture to secure the tissue to the bone,which is tedious and time-consuming. The surgical procedure would beless cumbersome for the surgeon and ultimately more beneficial to thepatient if the tissue could be attached to the bone without the surgeonhaving to tie suture knots.

SUMMARY

Illustrative embodiments disclosed below are useful for securing softtissue to bone with excellent pull-out strength without requiring asurgeon to tie suture knots to secure the suture in place or to securethe tissue to the bone. The disclosed examples may be used to secure anytype of soft tissue, graft, or tendon.

An illustrative example suture securing assembly includes an inserterhaving a distal end, a proximal end, and a longitudinal axis between thedistal end and the proximal end. A first member includes an eyeletoriented to thread suture across the longitudinal axis. The first memberis situated near the distal end of the inserter. The first member isconfigured to be placed in bone. A second member is situated near thedistal end of the inserter. The second member is moveable relative tothe first member in a distal direction toward the eyelet into a suturesecuring position where the second member traps suture.

Another illustrative example suture securing assembly includes a driverhaving a length and a width. The length is greater than the width. Thelength is parallel to an insertion direction. A first member issupported by the driver. The first member comprises an eyelet includingan opening that is transverse to the length. The opening is configuredto allow suture to be threaded through the eyelet transverse to thelength. The first member is situated to be moved in the insertiondirection to be received in bone. A second member is supported by thedriver. The second member is situated to be moved in the insertiondirection relative to at least the first member into a suture securingposition where the second member traps suture.

Various features and advantages associated with disclosed embodiments ofthe present invention will become apparent from the following detaileddescription, which refers to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a proximal end, side elevational view of aninterference screw according to an embodiment of the present invention.

FIG. 2 is a proximal end view of the screw shown in FIG. 1.

FIG. 3 is a cross-sectional view, drawn along line III-III of FIG. 2, ofthe screw shown in FIG. 1.

FIG. 4 illustrates a side elevational view of an interference plugaccording to an embodiment of the present invention.

FIG. 5 is a cross-sectional view of the plug shown in FIG. 4.

FIG. 6 is a distal end view of the plug shown in FIG. 6.

FIG. 7 illustrates a driver according to an embodiment of the presentinvention for driving the interference screw shown in FIG. 1.

FIG. 8 shows a handle according to a variation of the driver seen inFIG. 7.

FIG. 9 shows the inner shaft attachable to the driver handle shown inFIG. 8.

FIG. 10 shows the outer shaft of the driver according to an embodimentof the present invention.

FIG. 11 illustrates an alternative embodiment of a driver and aninterference screw.

FIGS. 12A and 12B illustrate a driver according to an embodiment of thepresent invention usable for the interference plug shown in FIG. 4.

FIG. 13 illustrates a punch usable in connection with an embodiment ofthe present invention to create a bone socket for securing the graft.

FIG. 14 illustrates a graft to be secured to the bone with attachedsutures, and a socket created in the bone at the location at which thegraft is to be affixed.

FIG. 15 shows the driver of FIG. 7 loaded with an interference screw andhaving a traction suture loop formed near the distal end of the driver.

FIG. 16 illustrates the sutures attached to the graft being passedthrough the suture loop according to an embodiment of present invention.

FIG. 17 is a view through a cross-section of the bone socket which showsthe sutures attached to the graft being held in contact with the bottomof the bone socket with the interference screw positioned just out ofthe socket.

FIG. 18A is a view through a cross-section of the bone through thesocket.

FIG. 18B illustrates the same step of the invention as shown in FIG.18A, but provides a close-up view from the surgeon's perspective.

FIG. 19 shows the graft secured to the bone as a result of a methodaccording to an embodiment of the present invention.

FIG. 20 illustrates an alternative embodiment of a method according tothe present invention in which the sutures attached to the graft arethreaded directly into and through the driver instead of through asuture loop at the distal end of the driver.

FIG. 21 illustrates a perspective view of a distal end of a push lockdriver of an embodiment of the present invention.

FIG. 22 illustrates a perspective view of the push lock driver of FIG.21.

FIG. 23 is a schematic cross-sectional view of a surgical siteundergoing a graft fixation technique according to a method of anembodiment of the present invention.

FIG. 24 is a schematic view of the surgical site of FIG. 23 undergoing agraft fixation technique with the push lock driver of FIGS. 21 and 22.

FIG. 25 is a schematic view of the surgical site of FIG. 23 undergoing agraft fixation technique with the push lock driver of FIGS. 21 and 22and at a stage subsequent to that shown in FIG. 24.

FIG. 26 is a schematic view of the surgical site of FIG. 23 undergoing agraft fixation technique with the push lock driver of FIGS. 21 and 22and at a stage subsequent to that shown in FIG. 25.

FIG. 27 is a schematic view of the surgical site of FIG. 23 undergoing agraft fixation technique with the push lock driver of FIGS. 21 and 22and at a stage subsequent to that shown in FIG. 26.

FIG. 28 is a schematic view of an eyelet implant of an embodiment of thepresent invention secured by and locked into an interference device inaccordance with an embodiment of the present invention.

FIG. 29 illustrates a perspective view of a distal end of a push lockdriver in accordance with an embodiment of the present invention.

FIG. 30 illustrates a perspective view of a distal end of a push lockdriver in accordance with another embodiment of the present invention.

FIG. 31 illustrates a perspective view of a distal end of a push lockdriver in accordance with another embodiment of the present invention.

FIG. 32 illustrates another perspective view of the push lock driver ofFIG. 31 with a strand passed through an aperture of the push lock.

FIG. 33 is a schematic cross-sectional view of a surgical siteundergoing a graft fixation technique with the push lock driver of FIGS.31 and 32.

FIGS. 34 and 34A are schematic views of the surgical site of FIG. 33 ata graft fixation stage subsequent to that shown in FIG. 33.

FIGS. 35 and 35A are schematic views of the surgical site of FIG. 33 ata graft fixation stage subsequent to that shown in FIGS. 34 and 34A.

DETAILED DESCRIPTION

Referring to FIGS. 1-3, an interference screw 10 according to anembodiment of the present invention is shown. Screw 10 is preferablyformed of a bioabsorbable material such as PLLA and has a cannulatedbody 12 provided with a continuous thread 16 having rounded outer edges18. The head 14 of the screw is rounded to minimize abrasion or cuttingof tissue, and the screw tapers toward the distal end. A hexagonal bore15 formed through the screw accepts a driver shaft described in moredetail below.

FIGS. 4-6 illustrate an interference plug 20 according to an alternativeembodiment of the present invention. Plug 20 is also preferably formedof a bioabsorbable material and has a cannulated body 22 provided withrounded annular ribs 24 separated by rounded annular grooves 26. Theouter diameter of the ribs and grooves is substantially constant. Theplug tapers significantly toward the distal end. Cannula 28 ispreferably round in cross-section but may also be hexagonal or any othershape, and is designed to accommodate the shaft of a correspondingdriver.

FIG. 7 illustrates a driver 30 according to an embodiment of the presentinvention for driving the interference screw described above. Generally,driver 30 includes a handle 32, inner shaft 34, and outer shaft 36. FIG.8 shows a handle having a connector 31 for coupling with driver 30.

FIG. 9 shows the inner shaft of driver 30. Inner shaft 34 has a cannulaextending through its entire length and has openings at the proximal anddistal ends to enable sutures to be passed therethrough. Inner shaft 34includes a shaft body 38 having a threaded proximal section 39 and ahex-shaped distal section 35 for being fitted through the cannula 15 ininterference screw 10. The diameter of the shaft body 38 is reducedslightly along the hex section 35, forming a shoulder 37 at the junctionbetween the hex section 35 and the central portion of shaft body 38 forabutting the proximal end of an interference screw loaded onto thedriver. Shaft 34 can be permanently affixed to the handle 32 as shown inFIG. 7, or can be releasably attached, as shown in the embodimentrepresented in FIGS. 8 and 9, by means of a collet 33 at the proximalend of the threaded section 39 being fittable within a connector 31 atthe distal end of handle 32.

FIG. 10 shows the outer shaft 36 of the driver 30. Outer shaft 36includes a sleeve 40 which covers and is slidable over shaft body 38,and a thumb pad 41 for being gripped by a user. Outer shaft 36 iscannulated through its entire length, of course, with the diameter ofthe cannula being slightly larger than the outer diameter of the centralportion of inner shaft body 38. The portion of the cannula through thumbpad 41 is threaded to mate with the threads on the threaded proximalsection 39 on inner shaft 34. The inner diameter of the inner threads inthumb pad 41 is smaller than the outer diameter of the central portionof shaft body 38, so as to limit the proximal movement of the outershaft 36 relative to the inner shaft 34.

The proximal threaded section 39 on the inner shaft 34 has a length suchthat when the outer shaft 36 is unscrewed to its proximal-most positionwith the thumbpad adjacent the distal end of handle 32 or connector 31,shoulder 37 on the inner shaft 34 is flush with or exposed through thedistal end of sleeve 40 of outer shaft 36.

The length of hex section 35 is such that when a cannulated interferencescrew is loaded onto the driver with the proximal end of the screwabutting the shoulder 37, the hex driver portion exposed distally of themounted screw can reach the bottom of a socket created in the bone wherethe screw will be inserted, while the screw is positioned just outsidethe hole. Thus, the hex section 35 has a length which is approximatelytwice the length of the interference screw usable with the driver.Similarly, the length of the threaded proximal section 39 is alsoapproximately equal to the length of the screw.

An alternative embodiment of the driver for the interference screw isshown in FIG. 11. In this embodiment, the outer shaft is eliminated sothat the driver 30′ is comprised of a single cannulated shaft. The shaftbody 38′ has an enlarged outer diameter relative to that of the previousembodiment, and tapers down to hex section 35′ via a tapered section37′. When loading a screw onto the driver 30′, the proper initialposition of the screw is established by inserting the hex sectionthrough the cannula of the screw until the travel of the proximal end ofthe screw 10 is limited by the increased diameter in tapered section37′. As before, the hex section has a length which enables the distalend of the hex section to be inserted to the bottom of the socket whilepositioning an intereference screw loaded onto the driver just outsidethe socket with the bottom thread of the screw able to engage theopening of the hole upon the application of a small amount of force intothe hole.

FIGS. 12A and 12B illustrate an example of a driver usable with aninterference plug in accordance with an embodiment of the presentinvention, in which the plug is driven into the socket by impactionrather than being screwed into place. Driver 50 comprises essentially ofan outer shaft 52 and a cannulated inner shaft 54. Inner shaft 54 isinserted into the cannula 51 of outer shaft 52 and has a proximalportion 55 which has an outer diameter slightly smaller than thediameter of cannula 51 to enable the outer shaft 52 to slide alongproximal portion 55. Inner shaft 54 also has a distal portion 57 whichhas a diameter smaller than that of proximal portion 55 and sized forinsertion into the cannula 28 of interference plug 20. Thecross-sectional shape of distal portion 57, and hence of cannula 28 ofplug 20, is preferably round, but can also be hex or any other shape, aslong as the distal portion 57 of inner shaft 54 is matingly shaped withthe distal portion 57 of driver 50 to be insertable into cannula 28 ofplug 20. The junction between proximal portion 55 and distal portion 57forms shoulder 56 for abutting the proximal end of the plug when theplug is loaded onto the driver 50.

The length of outer shaft 52 is equal to the length of proximal portion55 of inner shaft 54 plus a distance “a” equal to the length of theinterference plug usable therewith. The length of distal section 57 isapproximately equal to twice the length of a plug 20, and shoulder 56 onthe inner shaft 54 is flush with or just exposed through the distal endof outer shaft 52 when outer shaft 52 is in its fully retracted(proximal) position.

A method of performing soft tissue fixation in accordance with anembodiment of the present invention will now be described with referenceto FIGS. 14-19.

As shown in FIG. 14, sutures 62 are passed through the graft 60 atdesired points, and a blind hole or socket 66 is created in the bone 64,using a drill or punch, at the location where the tissue is to besecured. A punch provides the advantages of rounding the opening edge ofthe bone socket to protect the sutures attached to the graft from beingsheared during the insertion process, and also compacts the bone at thepunch site for better purchase of the bone by the anchor in cases wherethe bone is a soft bone. An example of such a punch is illustrated inFIG. 13, the punch having a constant diameter section 72, a tip 74, aflared section 76, and a main body portion 78. The diameter of theconstant diameter section corresponds to the diameter of the driver.

Next, as shown in FIG. 15, driver 30 is pre-loaded with screw 10 withouter shaft 36 in the fully retracted position and the distal end of thescrew abutting shoulder 37 of inner shaft 34 and the distal end surfaceof outer shaft 36. Traction suture 68 is passed into the cannula of thedriver, such that a looped end 70 is exposed at the distal end of thedriver. Sutures 62 attached to graft 60 are then passed through tractionsuture loop 70 at the end of driver 30 as seen in FIG. 16, to positionthe graft at an appropriate distance from the distal end of driver 30,either at a distance corresponding to the length of the screw or so thatthe graft is located directly at the distal end of the driver.

Referring now to FIG. 17, the driver 30 is held with gentle pressurewith the distal end of hex section 35 at the bottom of the hole 66,keeping the screw 10 just outside the hole. Tension can then be placedon the graft sutures 62 by drawing on traction suture 68 to tightensuture loop 70. Once adequate tension is achieved on the sutures, thedriver is manipulated so that the first thread edge of the screw engagesthe bone at the edge of the hole 66. The driver is turned by rotatinghandle 32 and thus inner shaft 34 while preventing outer shaft 36 fromrotating by holding thumb pad 41 in place during rotation of handle 32.This maneuver causes the outer shaft to move distally along the innershaft by the interaction of the inner threads in the outer shaft 62 withthe threads on threaded portion 39 of inner shaft 34, while also causingthe screw threads to engage the sides of the hole and pull the screwinto the hole. The inner shaft of the driver thus rotates withoutadvancing further into the hole, while the outer shaft guides theinsertion of the screw into the socket. In this manner, the screwadvances along the hex section of the driver until the screw is fullyinstalled to the position shown in FIGS. 18A and 18B, with sutures 62 orthe graft 60 pinned and/or wound between the base and sidewall of socket66 and interference screw 10. Optionally, sutures 62 may be twistedtogether at the time they are passed through loop 70 to increase contactwith the screw upon insertion of the screw into the socket.

After the screw is fully inserted, traction loop 70 is disengaged fromthe handle, and the driver is removed. As seen in FIG. 19, the ends ofthe sutures can be removed by clipping them short, leaving the graftsecurely fastened in place to the bone.

A procedure similar to that just described is performed with respect tothe installation of an interference plug, except that a driver such asdriver 50 shown in FIGS. 12A and 12B is used instead of driver 30 ofFIGS. 7-10, and the plug is advanced into the hole using impact forcesupplied by a mallet, for example, rather than by turning. When theproximal end of outer shaft 52 is hit with the mallet, the proximal endof plug 20 abutting against shoulder 56 on the inner shaft 54 and thedistal surface of outer shaft 52 pushes the plug into the socket 66. Inthis method, the plug is fully inserted into the hole when the proximalend of outer shaft 52 is flush with the proximal end of inner shaft 54.

In a first alternative to the method described above, sutures 62attached to the graft 60 are eliminated, so that in the step shown inFIG. 16, the graft itself is passed through the suture loop 70 to besecured from the bottom of the hole 66 by the tip of plug 20.

In an alternative to the method described above, traction suture 68 andloop 70 are eliminated, so that in the step shown in FIG. 16, instead ofpassing sutures 62 through loop 70, the ends of sutures 62 are threadedinto the cannula of the inner shaft 34 through the distal end thereof,through the length of driver 30 or 50, and out the opening at theproximal end thereof, as illustrated in FIG. 20.

FIGS. 21 and 22 illustrate an implant driver 100 of another embodimentof the present invention. Driver 100 includes a body 104, preferably inthe form of a cylinder, and having a distal end 112 (FIG. 21) and aproximal end 113 (FIG. 22). The body 104 of driver 100 includes an outershaft 117 and an inner shaft 119. The outer shaft 117 is cannulated forreceiving inner shaft 119.

As illustrated in FIG. 21, driver 100 is pre-loaded with an interferencedevice 120. Preferably, the interference device 120 is a screw or aninterference plug, preferably formed of a bioabsorbable material such asPLLA. If a screw is employed, the screw may be provided with acannulated body provided with a continuous thread having rounded outeredges. The head of the screw may be rounded to minimize abrasion orcutting of tissue. The cannulation formed through the screw ispreferably hex-shaped and accepts the correspondingly shaped inner shaft119 of driver 100. If an interference plug is desired, the plug isprovided with rounded annular ribs separated by rounded annular grooves.The outer diameter of the ribs and grooves is substantially constant.The plug tapers significantly toward the distal end. The plug alsocomprises a cannula, preferably hex-shaped, for accommodating the innercorrespondingly shaped shaft 119 of the corresponding driver 100.

As also shown in FIG. 21, an eyelet implant 150 is provided at thedistal end 112 of driver 100. The eyelet implant 150 is releasablyattached to the distal end 112 of driver 100 by means of a connector157. The eyelet implant 150 is formed of a transparent polymer material,and is preferably made of a bioabsorbable material such as PLLA,polyglycolic or polylactic acid polymers. Advantageously, the eyeletimplant 150 is made of a material similar to that of the interferencedevice 120. As illustrated in FIG. 21, the eyelet implant 150 isprovided with aperture 155 for receiving a suture attached to a graft topass through the eyelet implant 150, as described in more detail below.The width “w” (FIG. 21) of the eyelet implant 150 is about equal thediameter of the inner shaft 119 and slightly smaller than the diameterof the outer shaft 117 and of the cannula of the interference device120.

FIG. 22 illustrates proximal end 113 of driver 100, showing a handle 115disposed coaxially with the body 104 and outer shaft 117 and providedwith handle slots or protuberances 116. As described below, handle slotsor protuberances 116 allow a suture strand to be wrapped around thehandle 115 and be subsequently tensioned prior to the impaction of theinterference device 120 into the pilot hole. In this manner, the graftis precisely positioned at an appropriate distance from the pilot hole,and the suture with the attached graft is secured at the bottom of thepilot hole and prevented from exiting the pilot hole.

A method of a graft fixation technique according to an embodiment of thepresent invention is now described with reference to FIGS. 23-28. Thepresent invention may be used to secure any type of soft tissue, graft,or tendon, such as, for example, a biceps tendon or a rotator cuff. FIG.23 illustrates at least one suture 180 passed though the graft 170 atdesired points. FIG. 23 also illustrates a pilot hole or socket 190formed in the bone or cartilage 193 using a drill or punch, at thelocation where the tissue is to be secured. A punch provides theadvantages of rounding the opening edge of the bone socket to protectthe sutures 180 attached to the graft 170 from being sheared during theinsertion process, and also compacts the bone at the punch site forbetter attachment of the bone by the anchor in cases where the bone is asoft bone.

Next, as shown in FIG. 24, driver 100 with a pre-loaded interferencedevice 120 and with the outer shaft 117 in the retracted position isprovided in the proximity of the bone socket 190. Sutures 180 attachedto the graft 170 are subsequently passed through the aperture 155 of theeyelet implant 150 at the end of driver 100, as shown in FIG. 24.

Referring now to FIG. 25, driver 100 is held with gentle pressure sothat the eyelet implant 150 at the distal end 112 is held at the bottomof the hole 190, keeping the interference device 120 just outside thepilot hole 190. Tension is then applied to the suture 180 by wrappingthe suture 180 around the slots 116 of the handle 115 and tensioning it,as shown in FIGS. 26-27. The suture 180 freely slides through aperture155 of the eyelet implant 150, allowing the graft 170 to be positionedclose to the edge of the pilot hole 190. Once tensioning of the suture180 has been completed, the interference device 120 is then impactedinto the pilot hole 190 so that the interference device 120 advancestoward the distal end 112 of driver 100 and securely engages and locksin the eyelet implant 150 with the sutures 180, as shown in FIGS. 27-28.After the interference device 120 is fully inserted, the driver isremoved and the ends of the sutures can be removed by clipping themshort, leaving the graft 170 securely fastened to bone 193.

A significant advantage of the present invention is that the suturesattached to the graft or the graft itself can be securely attached tothe bone without the need to tie knots. Additionally, the sutureattached to the graft is secured both by the eyelet implant and by theinterference device, along the bottom and sidewalls of the pilot holebetween the bone and the screw or plug, conferring a much strongerfixation of the graft to the bone than is achievable with prior artprocedures and devices. More importantly, the suture attached to thegraft is allowed to freely slide though the aperture of the eyeletimplant to allow precise advancement and guiding of the plug or screwinto the blind hole or socket during the procedure.

In another embodiment of the present invention illustrated in FIG. 29,driver 200 is provided with a horseshoe-shaped implant 250 (i.e., animplant with an open distal end) at the distal end of the driver in lieuof the eyelet implant. The horseshoe-shaped implant 250 is provided inthe form of a wedge 255 that allows the suture attached to a graft to besecurely contained within the wedge, yet be capable to freely slidewithin the wedge. The horseshoe-shaped implant 250 is formed of atransparent polymer material, and is preferably made of a bioabsorbablematerial such as PLLA, polyglycolic or polylactic acid polymers.Advantageously, the horseshoe-shaped implant 250 is made of a materialsimilar to that of the interference device 20.

The horseshoe-shaped implant 250 may be detachable from the distal end112 of the driver 200, similar to the eyelet implant described in detailabove. In this embodiment, the detachable horseshoe-shaped implant 250is securely engaged within the cannulated ribbed body of theinterference plug or screw 120. Alternatively, the horseshoe-shapedimplant 250 may be integral with the distal end 112 of the driver 200and, after the interference screw or plug 120 is fully inserted into thepilot hole, the horseshoe-shaped implant 250 is removed from the sitetogether with the driver 200.

In yet another embodiment of the present invention and as illustrated inFIG. 30, driver 300 of the present invention is provided with a metaltubing 350 at the distal end of a driver, which in turn, is providedwith a cut or pair of protuberances 355 at its most distal end to allowat least one end of a suture attached to a graft to be securelycontained within the cut, yet be capable to freely slide within the cut.Preferably, the metal tubing 350 is integral with the distal end 112 ofthe driver 300 and, subsequent to the full insertion of the interferencescrew or plug 120 into the pilot hole, the metal tubing 350 is removedfrom the site together with the driver 300.

FIGS. 31-35 illustrate another embodiment of the present invention,according to which driver 400 is provided with a pointed tip implant 450at the distal end of the driver, which is also an eyelet implant butwhich, because of its pointed tip, does not require the pre-drilling orpre-formation of a hole for fixating the device (implant with sutureattached to graft) in the bone. The conical configuration of the mostdistal end of the pointed tip implant 450 allows the driver 400 with theattached implant to undergo a self-punching operation during graftfixation, eliminating any need to pre-drill a hole in the bone andproviding increased fixation of the overall operation of securing thesoft tissue. The conical configuration of the most distal end of thepointed tip implant 450 also provides suture fixation strength, as wellas accelerated graft/tendon healing to bone. The pointed tip implant 450may be detachable from the driver.

As illustrated in FIGS. 31 and 32, pointed tip implant 450 is providedwith an eyelet or aperture 455 for receiving at least one strand (forexample, a suture strand) attached to a graft to pass through the eyeletimplant 450. Pointed tip implant 450 is also provided, at its mostdistal end, with a conical portion 451 which allows direct advancementof the implant (by simply tapping the device with a mallet, for example)without the formation of a bone hole. Preferably, the conical portion451 of the implant is formed of titanium or titanium alloy. In apreferred embodiment, eyelet or aperture 455 is also formed of titaniumor similar material, to withstand impaction forces during the graftfixation procedure.

As in one of the previously-described embodiments, strand 180 (attachedto graft 170) is passed through the aperture 455 of the implant 450 atthe end of the driver 400, as shown in FIGS. 31 and 32. Although FIG. 32illustrate two strands 80 (i.e., two suture strands 180) passed throughthe aperture 455, the invention is not limited to this exemplaryembodiment and contemplates additional embodiments wherein one strand orany number of strands are passed through the aperture 455. Preferably,at least one of the strands is formed of a high strength suture materialsuch as FIBREWIRE® suture, sold by Arthrex, Inc. of Naples, Fla., anddescribed in U.S. Pat. No. 6,716,234, the disclosure of which isincorporated by reference herein. The high strength suture may beavailable in various lengths and widths. FIBREWIRE® suture is formed ofan advanced, high-strength fiber material, namely ultrahigh molecularweight polyethylene (UHMWPE), sold under the tradenames SPECTRA(Honeywell) and DYNEEMA (DSM), braided with at least one other fiber,natural or synthetic, to form lengths of suture material. The preferredFIBREWIRE® suture includes a core within a hollow braided construct, thecore being a twisted yarn of UHMWPE. The suture may optionally includefilaments of various colors.

An example method of graft fixation using the pointed tip implant 450 isillustrated with reference to FIGS. 33-35. This exemplary methodillustrated in FIGS. 33-35 relates to a specific graft fixationtechnique (i.e., SUTUREBRIDGE® Lateral Row fixation); however, theinvention is not limited to this exemplary embodiment and applies to anyother method of soft tissue fixation known in the art.

Referring to FIG. 33, an Arthrex SUTUREBRIDGE® medial row is completedas known in the art and the strands 180 (suture strands 180) arethreaded through the titanium eyelet 455. As shown in FIG. 34A, aprotective cap 194 (or other device that prevents anchor deployment) ismalleted to advance the PUSHLOCK® implant 450 until the anchor 420contacts bone 193. The suture is then tensioned, as shown in FIG. 34.The protective cap 194 is subsequently removed (FIG. 35A) and the button420 is malleted until a mark (for example, a predefined laser line) isflush with the bone (FIG. 35). The ribbed, spiked configuration of plugor button 420 facilitates the insertion of the device 400 into the boneby simply exerting force upon the device, without the need to drill orform a hole in the bone.

Although the above embodiments have been described including implantshaving an aperture of a predefined configuration (e.g., an eyelet orhorseshoe configuration), it should be understood that the invention isnot limited to these embodiments. Accordingly, the present inventionalso contemplates implants affixed to or detachable from a preloadeddriver and having an aperture of any configuration or geometrical shapethat captures suture and allows the captured suture to freely slidewithin the aperture until the suture is locked in place.

A significant advantage provided by the example methods is that thesutures attached to the graft or the graft itself can be securelyattached to the bone without the need to tie knots.

Another advantage achieved by the example embodiments of presentinvention is that the suture attached to the graft or the graft issecured both along the bottom of the bone socket by the tip of theinterference screw or plug, as well as along the sidewall of the socketbetween the bone and the screw or plug. This arrangement results in amuch stronger fixation of the graft to the bone than is achievable withprior art suture anchor procedures.

Although particular embodiments are described above, many othervariations and modifications and other uses will become apparent tothose skilled in the art who have the benefit of this description. Forexample, the various features of the example embodiments are notnecessarily limited to the particular embodiments shown in the drawings.One or more features of an embodiment may be combined with one or morefeatures of another to realize a different embodiment. Additionally,entirely different embodiments having similar features may be realized.The present invention cannot be limited by the specific disclosureherein, but only by the appended claims.

1. A suture securing assembly, comprising: an inserter including adistal end, a proximal end, and a longitudinal axis between the distalend and the proximal end; a first member including an eyelet oriented tothread suture across the longitudinal axis, the first member beingsituated near the distal end of the inserter, the first member beingconfigured to be placed in bone; and a second member situated near thedistal end of the inserter, the second member being moveable relative tothe first member in a distal direction toward the eyelet into a suturesecuring position where the second member traps suture.
 2. The assemblyof claim 1, wherein the second member is received on the inserterbetween the eyelet and the proximal end prior to movement into thesuture securing position.
 3. The assembly of claim 1, wherein the secondmember is moveable relative to the first member when the first member isin bone.
 4. The assembly of claim 1, wherein the second member traps thesuture against an exterior surface of the second member when the secondmember is in the suture securing position.
 5. The assembly of claim 4,wherein the second member is configured to trap suture by wedging suturebetween the second member and bone.
 6. The assembly of claim 5, whereinthe exterior surface of the second member is configured to engage boneto secure the second member in bone.
 7. The assembly of claim 1, whereinthe inserter is separable from the first member; the inserter isseparable from the second member; and the first member and the secondmember are configured to remain in bone for securing suture in bone. 8.The assembly of claim 1, wherein the second member comprises a screw. 9.The assembly of claim 1, wherein the second member comprises a plug. 10.The assembly of claim 1, wherein the inserter comprises a handle nearthe proximal end; a first shaft and a second shaft; the first shaftfacilitates inserting the first member into bone; and the second shaftfacilitates moving the second member into the suture securing position.11. The assembly of claim 10, wherein the second shaft is moveablerelative to the first shaft for moving the second member into the suturesecuring position.
 12. The assembly of claim 11, comprising a cap thatis moveable relative to the handle and connected with the second shaftfor moving the second shaft to cause the second member to move into thesuture securing position.
 13. The assembly of claim 10, wherein one ofthe first shaft or the second shaft is at least partially receivedwithin the other of the second shaft or the first shaft.
 14. Theassembly of claim 1, wherein the first member comprises a loop ofsuture.
 15. The assembly of claim 1, wherein the first member comprisesa rigid implant.
 16. A suture securing assembly, comprising: a driverhaving a length and a width, the length being greater than the width,the length being parallel to an insertion direction; a first membersupported by the driver, the first member comprising an eyelet includingan opening that is transverse to the length, the opening beingconfigured to allow suture to be threaded through the eyelet transverseto the length, the first member being situated to be moved in theinsertion direction to be received in bone; and a second membersupported by the driver, the second member being situated to be moved inthe insertion direction relative to at least the first member into asuture securing position where the second member traps suture.
 17. Theassembly of claim 16, wherein the second member is received on a portionof the driver in an initial position; and the second member is moveablealong the portion of the driver in the insertion direction into thesuture securing position.
 18. The assembly of claim 16, wherein thedriver has a distal end and a proximal end; the insertion directioncorresponds to a direction from the proximal end toward the distal end;and the first member is situated at least partially beyond the distalend of the driver.
 19. The assembly of claim 16, wherein the secondmember traps suture against an exterior surface of the second memberwhen the second member is in the suture securing position.
 20. Theassembly of claim 19, wherein the second member is configured to trapsuture by wedging suture between the second member and bone.
 21. Theassembly of claim 20, wherein the exterior surface of the second memberis configured to engage bone to secure the second member in bone. 22.The assembly of claim 16, wherein the driver is separable from the firstmember; the driver is separable from the second member; and the firstmember and the second member are configured to remain in bone forsecuring suture in bone.
 23. The assembly of claim 16, wherein thesecond member comprises a screw.
 24. The assembly of claim 16, whereinthe second member comprises a plug.
 25. The assembly of claim 16,wherein the driver comprises a handle and a rod extending from thehandle; the rod includes a first shaft and a second shaft; the firstshaft facilitates inserting the first member into bone; and the secondshaft facilitates moving the second member into the suture securingposition.
 26. The assembly of claim 25, wherein the second shaft ismoveable relative to the first shaft for moving the second member intothe suture securing position.
 27. The assembly of claim 26, wherein thehandle is at least partially moveable relative to at least the firstshaft for moving the second shaft to cause the second member to moveinto the suture securing portion.
 28. The assembly of claim 25, whereinone of the first shaft or the second shaft is at least partiallyreceived within the other of the second shaft or the first shaft. 29.The assembly of claim 16, wherein the first member comprises a loop ofsuture.
 30. The assembly of claim 1, wherein the first member comprisesa rigid implant.